BACKGROUND: The evaluation of electronic patient-reported outcomes (ePROs) is increasingly being used in clinical studies of patients with cancer and enables structured and standardized data collection in patients\' everyday lives. So far, few studies or analyses have focused on the medical benefit of ePROs for patients.
OBJECTIVE: The current exploratory analysis aimed to obtain an initial indication of whether the use of the Consilium Care app (recently renamed medidux; mobile Health AG) for structured and regular self-assessment of side effects by ePROs had a recognizable effect on incidences of unplanned consultations and hospitalizations of patients with cancer compared to a control group in a real-world care setting without app use. To analyze this, the incidences of unplanned consultations and hospitalizations of patients with cancer using the Consilium Care app that were recorded by the treating physicians as part of the patient reported outcome (PRO) study were compared retrospectively to corresponding data from a comparable population of patients with cancer collected at 2 Swiss oncology centers during standard-of-care treatment.
METHODS: Patients with cancer in the PRO study (178 included in this analysis) receiving systemic therapy in a neoadjuvant or noncurative setting performed a self-assessment of side effects via the Consilium Care app over an observational period of 90 days. In this period, unplanned (emergency) consultations and hospitalizations were documented by the participating physicians. The incidence of these events was compared with retrospective data obtained from 2 Swiss tumor centers for a matched cohort of patients with cancer.
RESULTS: Both patient groups were comparable in terms of age and gender ratio, as well as the distribution of cancer entities and Joint Committee on Cancer stages. In total, 139 patients from each group were treated with chemotherapy and 39 with other therapies. Looking at all patients, no significant difference in events per patient was found between the Consilium group and the control group (odds ratio 0.742, 90% CI 0.455-1.206). However, a multivariate regression model revealed that the interaction term between the Consilium group and the factor \"chemotherapy\" was significant at the 5% level (P=.048). This motivated a corresponding subgroup analysis that indicated a relevant reduction of the risk for the intervention group in the subgroup of patients who underwent chemotherapy. The corresponding odds ratio of 0.53, 90% CI 0.288-0.957 is equivalent to a halving of the risk for patients in the Consilium group and suggests a clinically relevant effect that is significant at a 2-sided 10% level (P=.08, Fisher exact test).
CONCLUSIONS: A comparison of unplanned consultations and hospitalizations from the PRO study with retrospective data from a comparable cohort of patients with cancer suggests a positive effect of regular app-based ePROs for patients receiving chemotherapy. These data are to be verified in the ongoing randomized PRO2 study (registered on ClinicalTrials.gov; NCT05425550).
BACKGROUND: ClinicalTrials.gov NCT03578731; https://www.clinicaltrials.gov/ct2/show/NCT03578731.
UNASSIGNED: RR2-10.2196/29271.

BACKGROUND: With an increasing collection of patient-reported outcomes (PROs) to measure health-related quality of life (HRQoL) in oncological patients, there is still a lack of standardised strategies on how to interpret and use these data in patient care. Prior research has shown support for the use of digital PRO monitoring together with alarm systems to notify clinicians when the PRO values are deteriorating. This system has demonstrated advantages in improving HRQoL and increasing survival rates among oncology patients. Hence, we designed the PRO B study, a superiority multi-centre randomised controlled trial, to investigate the effects of alarm-based monitoring in metastatic breast cancer patients in Germany. The study protocol for the PRO B study was published in September 2021, and this manuscript describes a formal statistical analysis plan (SAP) for the PRO B study to improve the transparency and quality of this trial.
METHODS: The trial aimed to recruit 1000 patients with metastatic breast cancer. However, as of the completion of recruitment on June 15, 2023, we have successfully enrolled 924 patients from 52 breast cancer centres. Patients were 1:1 stratified randomised to the intervention and control groups. App-based PRO questionnaires are sent weekly to the intervention group and every 3 months to the control group. Only patients in the intervention group trigger an alarm if their PRO scores deteriorate, and they are subsequently contacted by the local care team within 48 h. The primary outcome is the fatigue score at 6 months, and secondary outcomes are other HRQoL and overall survival. Evaluation of the superiority of the intervention will be done using a linear mixed model with random intercepts for study centres.
CONCLUSIONS: This detailed SAP defines the main components of the statistical analysis for the PRO B study to assist the statistician and prevent bias in selecting analysis and reporting findings. Version 1 of the SAP was finalised on January 18, 2024.
BACKGROUND: DRKS (German Clinical Trials Register) DRKS00024015 . Registered on February 15, 2021.

Timely collection of patient-reported outcomes (PROs) decreases emergency department visits and hospitalizations and increases survival. However, little is known about the outcome predictivity of unpaid informal caregivers\' reporting using similar clinical outcome assessments.
The aim of this study is to assess whether caregivers and adults with cancer adhered to a planned schedule for electronically collecting patient-reported outcomes (PROs) and if PROs were associated with future clinical events.
We developed 2 iPhone apps to collect PROs, one for patients with cancer and another for caregivers. We enrolled 52 patient-caregiver dyads from Kaiser Permanente Northern California in a nonrandomized study. Participants used the apps independently for 4 weeks. Specific clinical events were obtained from the patients\' electronic health records up to 6 months following the study. We used logistic and quasi-Poisson regression analyses to test associations between PROs and clinical events.
Participants completed 97% (251/260) of the planned Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) surveys and 98% (254/260) of the Patient-Reported Outcomes Measurement Information System (PROMIS) surveys. PRO-CTCAE surveys completed by caregivers were associated with patients\' hospitalizations or emergency department visits, grade 3-4 treatment-related adverse events, dose reductions (P<.05), and hospice referrals (P=.03). PROMIS surveys completed by caregivers were associated with hospice referrals (P=.02). PRO-CTCAE surveys completed by patients were not associated with any clinical events, but their baseline PROMIS surveys were associated with mortality (P=.03), while their antecedent or final PROMIS surveys were associated with all clinical events examined except for total days of treatment breaks.
In this study, caregivers and patients completed PROs using smartphone apps as requested. The association of caregiver PRO-CTCAE surveys with patient clinical events suggests that this is a feasible approach to reducing patient burden in clinical trial data collection and may help provide early information about increasing symptom severity.

暂无摘要。

UNASSIGNED: By eliminating the requirement for participants to make frequent visits to research sites, mobile phone applications (\"apps\") may help to decentralize clinical trials. Apps may also be an effective mechanism for capturing patient-reported outcomes and other endpoints, helping to optimize patient care during and outside of clinical trials.
UNASSIGNED: We report on the usability of Digital BioMarkers for Clinical Impact (DigiBioMarC™ (DBM)), a novel smartphone-based app used by cancer patients in conjunction with a wearable device (Apple Watch®). DBM is designed to collect patient-reported outcomes and record physical functions.
UNASSIGNED: In a fully decentralized \"bring-your-own-device\" smartphone study, we enrolled 54 cancer patient and caregiver dyads from Kaiser Permanente Northern California (KPNC) from October 2020 through March 2021. Patients used the app for at least 28 days, completed weekly questionnaires about their symptoms, physical functions, and mood, and performed timed physical tasks. Usability was determined through a subset of the Mobile App Rating Scale (MARS), the full System Usability Scale (SUS), the Net Promoter Score (NPS), and semi-structured interviews.
UNASSIGNED: We obtained usability survey data from 50 of 54 patients. Median responses to the selected MARS questions and the mean SUS scores indicated above average usability. The NPS from the semi-structured interviews at the end of the study was 24, indicating a favorable score.
UNASSIGNED: Cancer patients reported above average usability for the DBM app. Qualitative analyses indicated that the app was easy to use and helpful. Future work will emphasize implementing further patient recommendations and evaluating the app\'s clinical efficacy in multiple settings.

The global demand for hospital treatment exceeds capacity.The COVID-19 pandemic has exacerbated this issue, leading to increased backlogs and longer wait times for patients. The amount of outpatient attendances undertaken in many settings is still below pre-pandemic levels and this, combined with delayed referrals, means that patients are facing delays in treatment and poorer health outcomes. Use of digital health technologies, notably the use of remote symptom monitoring systems based on patient-reported outcomes (PROs), may offer a solution to reduce outpatient waiting lists and tailor care to those in greatest need. Drawing on international examples, the authors explore the use of electronic PRO systems to triage clinical care. We summarise the key benefits of the approach and also highlight the challenges for implementation, which need to be addressed to promote equitable healthcare delivery.

Routine collection of electronic patient-reported outcomes (ePROs) can improve clinical care. However, a low response rate may counteract the benefits. To optimize adoption, the aim of this study was to investigate which patient factors and/or timing of the invitation predicted response to ePROs sent prior to consultations in patients with rheumatoid arthritis. We performed a retrospective database study with clinical data collected as part of usual care from the electronic medical records at Reade Amsterdam. The dataset comprised the email invitations to complete the ePRO sent prior to consultation. Multiple patient factors and factors defining the timing of the invitation were investigated if they predicted response to the ePRO through a multivariable logistic generalized estimating equation analysis. In total, 17.070 ePRO invitations were sent to 3194 patients (mean age 60 (SD 14), 74% female), of which 40% was completed. Patients between 55 and 73 years (OR 1.39, 95%CI 1.09-1.77) and with higher social economic status (SES) (OR 1.51, 95%CI 1.22-1.88) had significantly higher odds for completing the ePRO, while patients living in an urban area had lower odds (OR 0.69, 95% CI 0.62-0.76). In year 4 after implementation, the OR was increased to 3.69 (95% CI 2.91-4.90). The implementation of ePROs in daily clinical practice needs improvement since 40% of the ePROs sent prior to consultations were completed. Patients that had higher odds to report the next ePRO were between the age of 55-73, had a higher socio-economic status, and were residents in a rural area. The adoption of reporting the PRO increased over time, but the timing of the prompt did not predict response. Additional research is needed to understand ePRO completion, especially for patients with lower socio-economic status.

In preparation for the PRO B study which aims to examine the effects of an app-based intensified patient-reported outcome (PRO) monitoring for metastatic breast cancer patients, prior assessment of its feasibility was carried out. Sixteen breast cancer patients visiting the breast cancer unit at Charité were recruited and downloaded an app connected to an ePRO system. They received electronic questionnaires on two occasions (baseline and the following week) and were subsequently contacted for a semi-structured phone interview for evaluation. Eleven participants answered at least one questionnaire. Some participants did not receive any or only a part of the questionnaires due to technical problems with the app. Participants who completed the evaluation questionnaire (n = 6) were overall satisfied with the weekly PRO questionnaire. All interviewed (n = 11) participants thought it was feasible to answer the PRO questionnaires on a weekly basis for one year, as planned in the PRO B study. The pretest revealed a need for major technical adjustments to the app because push notifications about the receipt of new questionnaires were not displayed on some smartphone models. Due to the low number of participants, generalization of the findings is limited to our specific context and study. Nevertheless, we could conclude that if technical aspects of the app were improved, the PRO B study could be implemented as planned. The ePRO questionnaire was considered feasible and adequate from the patients\' perspectives.

Details of the development and implementation of integrated care pathways (ICPs) in the context of electronic collection of patient reported outcomes (ePROs) for cancer patients are largely lacking in the literature. This study describes what, why and how decisions were made to adapt and implement an ePROs ICP for patients with lung cancer.
A consensus process was utilized, with the implementation advisory group including multidisciplinary representation from three participating hospitals, to identify local champions and adapt and incorporate the ePRO ICP into the local contexts. Engagement meetings were documented via meeting transcripts, and detailed notes from October 2019 to November 2020 were content-analysed to identify decision-making themes based on the Consolidated Framework for Implementation Research; workflows and process maps were reviewed and modified to integrate ePROs.
In total, 55 engagement activities were held (24 meetings, 20 workshops 11 educational sessions), with n = 96 staff from multiple disciplines participating in the ePROs implementation through advisory meetings, process mapping, change management and staff education. Decisions were made regarding eligible patient cohorts to include, the process for onboarding patients onto the ePRO system, and follow-up and referral pathways. Rationales for decisions included alignment with existing workflows, utilizing available staff, minimizing staff and patient burden and maximizing patient engagement.
Existing resources, staff input and technical and logistical reasons often guided the ICP decisions, highlighting the need for in-depth engagement across all stakeholders for optimal implementation of ePRO ICPs. The ePRO implementation required substantial dialogue and systematic resolution to reach agreement on the final processes. Adapting the local ICP through rigorous engagement facilitated the successful implementation of ePROs as business-as-usual at all three cancer centres. Involving all relevant stakeholders is critical to the successful adaptation of ICPs before their introduction into routine care.

Patient-reported outcomes (PROs) are an emerging paradigm in clinical research and healthcare, aiming to capture the patient\'s self-assessed health status in order to gauge efficacy of treatment from their perspective. As these patient-generated health data provide insights into the effects of healthcare processes in real-life settings beyond the clinical setting, they can also be viewed as a resolution beyond what can be gleaned directly by the clinician. To this end, patients are identified as a key stakeholder of the healthcare decision making process, instead of passively following their doctor\'s guidance. As this joint decision-making process requires constant and high-quality communication between the patient and his/her healthcare providers, novel methodologies and tools have been proposed to promote richer and preemptive communication to facilitate earlier recognition of potential complications. To this end, as PROs can be used to quantify the patient impact (especially important for chronic conditions such as cancer), they can play a prominent role in providing patient-centric care. In this paper, we introduce the MyPal platform that aims to support adults suffering from hematologic malignancies, focusing on the technical design and highlighting the respective challenges. MyPal is a Horizon 2020 European project aiming to support palliative care for cancer patients via the electronic PROs (ePROs) paradigm, building upon modern eHealth technologies. To this end, MyPal project evaluate the proposed eHealth intervention via clinical studies and assess its potential impact on the provided palliative care. More specifically, MyPal platform provides specialized applications supporting the regular answering of well-defined and standardized questionnaires, spontaneous symptoms reporting, educational material provision, notifications etc. The presented platform has been validated by end-users and is currently in the phase of pilot testing in a clinical study to evaluate its feasibility and its potential impact on the quality of life of palliative care patients with hematologic malignancies.